Special Report: Incannex Healthcare (ASX:IHL) is making steady progress on its hydroxychloroquine (HCQ)/cannabidiol (CBD) drug combination and will be meeting with US regulators shortly on an approval pathway.

The Melbourne-based pharmaceutical development company says it has a pre-investigational new drug (IND) meeting with the US Food and Drug Administration after submitting a comprehensive information package on IHL-675A and its proposed use in preventing Acute Respiratory Distress Syndrome (ARDS) and Sepsis Associated Acute Respiratory Distress Syndrome (SAARDS), a leading cause of death from COVID-19.

Some 10 to 15 per cent of all patients admitted to intensive care have ARDS, a life-threatening injury characterised by fluid leaking into the lungs, according to Incannex.

Patients with ARDS often have poor outcomes, as the ventilators typically only treat the symptoms rather than the inflammation that’s driving the disease.

The FDA says it will try to provide comment on Incannex’s drug development proposal by April 21, after which time Incannex will formalise its clinical development plans.

FDA members from across the agency, including representatives from medical, pharmacology and chemistry, manufacturing and control (CMC) divisions will provide feedback on Incannex’s plans.

“The United States is the largest pharmaceutical market in the world, so being granted a Pre-IND meeting review with FDA represents an important milestone for our company and a strong foundation for the clinical development of IHL-675A,” says Incannex managing director and chief executive Joel Latham.

Seven separate preclinical trials on IHL-675A have indicated the drug cocktail is a potent anti-inflammatory. The animal tests indicate that CBD and hydroxychloroquine work together synergistically to reduce inflammation.

In consultation with the FDA, Incannex intends to expand its development to include pulmonary neutrophilia, inflammatory bowel disease and rheumatoid arthritis.

“Our preclinical studies have demonstrated that IHL-675A has the potential to be a platform drug applicable to the treatment of multiple indications,” says Latham.

“We anticipate the work completed on the FDA information package for IHL-675A for ARDS and SAARDS will assist us with hastening submissions to FDA for the other indications being pursued.”


This article was developed in collaboration with Incannex Healthcare, a Stockhead advertiser at the time of publishing.

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.